Senior PV Associate

Bucharest, Bucharest, roFull-time2026-11-09 → 2026-11-10

Core

Managing Individual Case Safety Reports (ICSRs) and Safety Signal Management for pharmaceutical and biotechnology clients.

Role type

Senior Individual Contributor Pharmacovigilance Associate

Builds

ICSR databases, safety reports, and regulatory submissions for clients

Domain

Life Sciences / Pharmacovigilance

Required skills

ICSR processing, SAE/SUSAR management, MedDRA/WHO coding, data reconciliation, quality complaint handling, workflow management

Preferred skills

LCPPV (Local Contact Person for Pharmacovigilance) experience, PRLS (Person Responsible for Local Screening) experience

Technologies

PrimeVigilance platform, MS Office

Responsibilities

Processing ICSRs from all sources in compliance with regulations; performing ICSR follow-up; managing SAE/SUSARs (unblinding, reconciliation, protocol review); handling product quality complaints; generating database outputs and monthly client reports; acting as LCPPV and PRLS for designated countries/languages.

Seniority

Senior, hands-on IC

About Ergomed

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner.